FDA issued the document “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements”. The exemptions cover a many types of devices. The document is at the link provided.
IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.
October 13-15, 2026
Limited Early Bird Registration: $995 / person
Non refundable but transferable.
Or just email training@softwarecpr.com for more info.